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Medical Devices
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September 1996 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for September 1996. This list is generated on a monthly basis.
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.
PMA Original Approvals
PMA NUMBER/ DEVICE NAME COMPANY NAME/ APPROVAL STATEMENT/INDICATIONS APPR DATE ADDRESS P870080 HULKA CLIP TUBAL RICHARD WOLF MEDICAL INDICATED FOR USE FOR FEMALE 09/05/96 OCCLUSION DEVICE INSTRUMENTS CORP. STERILIZATION (PERMANENT AND APPLICATOR VERNON HILLS, IL CONTRACEPTION) BY OCCLUDING SYSTEMS 60061 THE FALLOPIAN TUBES P920034 TRIPTER-X1 SERIES MEDIREX, INC. INDICATED FOR USE IN THE 09/20/96 EXTRACORPOREAL FRAGMENTATION OF URINARY SHOCK WAVE WELLESLEY, MA TRACT STONES (I.E., RENAL LITHOTRIPTERS 02181 CALYCEAL, RENAL PELVIC, (TRIPTER-X1, AND UPPER URETERAL STONES) TRIPTER-X1 NOVA, AND TRIPTER-X1 COMPACT) P920046 FILSHIE CLIP FAMILY HEALTH INDICATED FOR PERMANENT 09/05/96 SYSTEM (MARK VI) INTERNATIONAL FEMALE STERILIZATION BY RESEARCH TRIANGLE, NC OCCLUSION OF THE FALLOPIAN 27709 TUBES P930021 EMDOGAIN BIORA US, INC. INDICATED FOR USE AS AN 09/30/96 ADJUNCT TO PERIODONTAL WEST CHESTER, OH SURGERY FOR TOPICAL 45069 APPLICATION ONTO EXPOSED ROOT SURFACES TO TREAT INTRABONY DEFECTS WITHOUT FURCATIONS, RESULTING FROM LOSS OF TOOTH SUPPORT DUE TO MODERATE OR SEVERE PERIODONTITIS P930038 ANGIO-SEAL KENSEY NASH CORP. INDICATED FOR USE IN CLOSING AND 09/30/96 HEMOSTATIC IN REDUCING TIME TO HEMOSTASIS PUNCTURE CLOSURE EXTON, PA AT THE FEMORAL ARTERIAL PUNCTURE DEVICE 19341 SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH P950002 BAK INTERBODY SPINE-TECH, INC. INDICATED FOR USE WITH AUTOGENOUS 09/20/96 FUSION SYSTEM BONE GRAFT IN PATIENTS WITH WITH MINNEAPOLIS, MN DEGENERATIVE DISC DISEASE (DDD) INSTRUMENTATION 55439-2029 AT ONE OR TWO CONTIGUOUS LEVELS FROM L2-S1 P950024 CAPSURE EPI MEDTRONIC, INC. INDICATED TO BE USED WITH A 09/06/96 PACING LEAD, PULSE GENERATOR AS PART OF A MODEL 4965 MINNEAPOLIS, MN CARDIAC PACING SYSTEM 55432-3576 P950042 XILLIX LIFE-LUNG HOGAN & HARTSON INDICATED FOR USE AS AN ADJUNCT 09/19/96 FLUORESCENCE TO WHITE LIGHT BRONCHOSCOPY, ENDOSCOPY SYSTEM WASHINGTON, DC USING AN OLYMPUS BF-20D 20004-1109 BRONCHOSCOPE, TO ENHANCE THE PHYSICIAN'S ABILITY TO IDENTIFY AND LOCATE BRONCHIAL TISSUE, SUSPICIOUS FOR MODERATE/SEVERE DYSPLASIA OR WORSE, FOR BIOPSY AND HISTOLOGIC EVALUATION IN THE FOLLOWING POPULATIONS: 1)PATIENTS WITH KNOWN OR PREVIOUSLY DIAGNOSED LUNG CANCER; AND 2)PATIENTS WITH SUSPECTED LUNG CANCER P960005 ACA PLUS PSA TEST DADE INTL., INC. THE DEVICE IS A PROSTATE SPECIFIC 09/09/96 KIT, ACA PLUS PSA ANTIGEN (PSA) TEST KIT, WHICH CALIBRATOR, AND NEWARK, DELAWARE CONSISTS OF THE PSA TEST PACK AND ACA PLUS PSA 19714 REACTION VESSEL USED IN THE ACA CONTROL PLUS IMMUNOASSAY SYSTEM TO QUANTITATIVELY MEASURE PSA IN HUMAN SERUM. MEASUREMENTS OF PSA ARE USED AS AN AID IN THE MANAGEMENT OF PROSTATE CANCER PATIENTS P960012 REFRESH CL ALLERGAN OPTICAL INDICATED FOR THE LUBRICATION AND 09/25/96 LUBRICATING AND REWETTING OF SOFT CONTACT LENSES REWETING DROPS IRVINE, CA AND HELPS TO RELIEVE DRYNESS, 92713-9534 DISCOMFORT AND IRRITATION THAT MAY BE ASSOCIATED WITH LENS WEAR
PMA Supplement Approvals
P780007/S041 POLYMACON AND OCULAR SCIENCES/ ALTERNATE MANUFACTURING FACILITY
09/27/96 POLYMACON EDGE AMERICAN HYDRON AT RELIANT CLOSE, CHANDLERS FORD
SOFT CONTACT S.SAN FRANCISCO, CA INDUSTRIAL ESTATE, CHANDLERS FORD,
LENSES 94080 EASTLEIGH, HAMPSHIRE, S053 4ND,
ENGLAND
P790017/S059 USCI PROCROSS C.R. BARD, INC. APPROVAL FOR USCI PROCROSS OVER-
09/03/96 OVER-THE-WIRE THE-WIRE BALLOON DILATATION CATHETER
BALLOON DILATATION BILLERICA, MA WITH RELY BALLOON MATERIAL AND
CATHETER WITH 01821 HYDRO/PEL COATING
RELY BALLOON
MATERIAL AND HYDRO/
PEL COATING
COATING
P800026/S011 PLIAGEL CLEANING ALCON LABORATORIES, APPROVAL FOR A STABILITY TESTING
09/24/96 SOLUTION INC. PROTOCOL
FORT WORTH, TX
76134
P800034/S016 CLERZ 2 ALCON LABORATORIES, APPROVAL FOR A STABILITY TESTING
09/24/96 LUBRICATING AND INC. PROTOCOL
REWETTING DROPS FORT WORTH, TX
76134
P810002/S041 ST. JUDE MEDICAL ST. JUDE MEDICAL, INC. NEW STERILE PACKAGE SYSTEM FOR ALL
09/04/96 MECHANICAL HEART OF THE ST. JUDE MEDICAL MECHANICAL
VALVE ST. PAUL, MN HEART VALVE MODELS
55117
P810046/S163 ACS PINKERTON GUIDANT CORP. APPROVAL FOR THE ACS PINKERTON .018
09/13/96 .018 CORONARY CORONARY DILATATION CATHETER WITH THE
DILATION CATHETER SANTA CLARA, CA 4.5 MM AND 5.0 MM BALLOON LENGTHS
(4.5 MM AND 5.0 MM 95052-8167
BALLOON LENGTHS)
P820021/S029 FOCUS AND CIBA VISION CORP. REVISED LABELING (I.E., PACKAGE
09/25/96 NEWVUES INSERT, PRACTITIONER FITTING GUIDE,
(VIFILCON A) SOFT DULUTH, GA SEPARATE PATIENT INFORMATION
(HYDROPHILIC) 30155-1518 BOOKLETS FOR LENSES PRESCRIBED FOR
CONTACT LENSES FREQUENT REPLACEMENT WEAR (FOCUS
FOCUS TORIC, AND NEWVUES
(VIFILCON A) SOFT (HYDROPHILIC)
CONTACT LENSES) AND DISPOSABLE
WEAR (NEWVUES (VIFILCON A) SOFT
HYDROPHILIC) CONTACT LENSES).
REVISIONS INCLUDE: 1)MERGING PLANNED
REPLACEMENT AND DISPOSABLE WEARING
SCHEDULES FOR THE LENSES INTO ONE
PACKAGE INSERT AND DIRECTING THE
PACKAGE INSERT TO THE EYECARE
PRACTITIONER, 2)WRITING SEPARATE
PATIENT INSTRUCTIONS FOR LENSES
PRESCRIBED FOR DISPOSABLE AND
FREQUENT REPLACEMENT WEAR, 3)UPDATING
AND PROFESSIONAL FITTING GUIDE FOR
CONSISTENCY WITH OTHER LABELING
ITEMS, AND 4)BRINGING THE LABELING
UP-TO-DATE WITH FDA'S CURRENT
RECOMMENDATIONS IN AN EFFORT TO
INCREASE CONSUMER COMPREHENSION AND
COMPLIANCE. THE REVISIONS DO NOT
RESULT IN CHANGES IN THE DEVICES
THEMSELVES OR THE INDICATIONS FOR USE
OF THE DEVICES.
P820083/S021 GORE-TEX SUTURE W.L. GORE & ASSOC., APPROVAL FOR COMBINING EPTFE PLEDGETS
09/24/96 INC. WITH GORE-TEX SUTURE AND APPROVAL
FLAGSTAFF, AZ FOR MODIFIED PACKAGING OF THE
86003-2300 GORE-TEX SUTURE
P820083/S022 GORE-TEX SUTURE W.L. GORE & ASSOC., APPROVAL FOR COMBINING EPTFE PLEDGETS
09/24/96 WITH PLEDGETS INC. WITH GORE-TEX SUTURE AND APPROVAL
FLAGSTAFF, AZ FOR MODIFIED PACKAGING OF THE
86002 GORE-TEX SUTURE
P830060/S041 MODELS 0012/0013 CPI/GUIDANT CORP. APPROVAL FOR MODELS 0012/0013 BIPOLAR
09/20/96 BIPOLAR ENDOCARDIAL ENDOCARDIAL LEADS; AND 0014/0015
LEADS; AND MODELS ST. PAUL, MN POSITIVE-FIXATION PROTECTED-HELIX
0014/0015 POSITIVE- 55112-5798 BIPOLAR ENDOCARDIAL LEADS TO BE USED
FIXATION PROTECTED- IN CONJUNCTION WITH AUTOMATIC
HELIX BIPOLAR IMPLANTABLE CARDIOVERTER
ENDOCARDIAL LEADS DEFIBRILLATOR (AICD ) PULSE
GENERATORS
P840024/S065 NUCLEUS 22- COCHLEAR CORP. APPROVAL FOR IMPLEMENTING A TEST
09/09/96 CHANNEL COCHLEAR SYSTEM TO CONFIRM OR RULE OUT
IMPLANT SYSTEM ENGLEWOOD, CO POTENTIAL IMPLANT MALFUNCTION
80112 AND FOR MARKETING OF ONE OF THE
COMPONENTS OF THIS TEST SYSTEM AS
A SEPARATE DEVICE. THE DEVICE
IS INDICATED FOR USE IN ADULTS WITH
BILATERAL, SENSORINEURAL, SEVERE-TO-
PROFOUND DEAFNESS, AGES 18 YEARS AND
OLDER, WHO OBTAIN UP TO 30% SPEECH
RECOGNITION ON TESTS OF RECORDED
SENTENCE MATERIALS IN THE BEST-AIDED
CONDITION. IT IS INDICATED FOR USE IN
CHILDREN WITH BILATERAL,
SENSORINEURAL, PROFOUND DEAFNESS,
AGES 2 YEARS TO 17 YEARS, WHO OBTAIN
LITTLE OR NO BENEFIT FROM
CONVENTIONAL AMPLIFICATION IN THE
BEST-AIDED TEST CONDITION
P840024/S067 NUCLEUS 22 COCHLEAR CORP. APPROVAL TO USE A CERAMIC LID ON THE
09/10/96 CHANNEL COCHLEAR IC2406 CERAMIC PACKAGE INSTEAD OF THE
IMPLANT SYSTEM ENGLEWOOD, CO KOVAR LID CURRENTLY USED
FOR USE WITH 80112
POSTLINGUISTICALLY
PROFOUNDLY DEAFENED
ADULTS
P850007/S014 SPINAL-STIM ORTHOFIX, INC. FINAL DRAFT LABELING MODIFIED TO
09/19/96 MODELS 8500 AND REFLECT THE LONG-TERM SUCCESS RATES
8212 RICHARDSON, TX DEVICE INDICATED AS A SURGICAL
75081 ADJUNCT FOR SPINAL FUSION OR AS A
NONOPERATIVE TREATMENT WHERE AT LEAST
NINE MONTHS HAVE ELAPSED SINCE THE
LAST SURGERY
P850007/S016 SPINAL-STIM ORTHOFIX, INC. FINAL DRAFT LABELING MODIFIED TO
09/19/96 MODELS 8500 AND REFLECT THE LONG-TERM SUCCESS RATES
8212 RICHARDSON, TX DEVICE INDICATED AS A SURGICAL
75081 ADJUNCT FOR SPINAL FUSION OR AS A
NONOPERATIVE TREATMENT WHERE AT LEAST
NINE MONTHS HAVE ELAPSED SINCE THE
LAST SURGERY
P850020/S008 PROSORBA CYPRESS BIOSCIENCE, LABELING CHANGES TO THE PACKAGE
09/27/96 COLUMN INC. INSERT (I.E., REVISIONS TO THE
SAN DIEGO, CA SECTIONS ENTITLED COLUMN
92121 PREPARATION, OFF-LINE PROCEDURE AND
ON-LINE PROCEDURE, INCLUDING MORE
DETAILED INSTRUCTIONS FOR USE,
ILLUSTRATIONS OF THE DEVICE SET-UP,
INCREASED PATIENT MONITORING AND
REFINEMENT OF SPECIFIED PLASMA FLOW
RATES) AND A PROCEDURE CHANGE
INVOLVING THE USE OF AN "IN-LINE"
LEUKOCYTE REMOVAL FILTER FOR
MICROAGGREGATE REMOVAL WHICH IS TO
BE INSERTED IN THE BLOOD LINE
RETURNING TREATED PLASMA TO THE
PATIENT
P850049/S005 COOK BIRD'S NEST COOK, INC. REVISED LABELING
09/17/96 VENA CAVA FILTER
BLOOMINGTON, IN
47402
P860004/S035 MEDTRONIC MODELS MEDTRONIC, INC. ADDITION TO THE LABELING FOR
09/10/96 8616-10 AND THE 10 CC SYNCHROMED
8617-10 (ALSO MINNEAPOLIS, MN IMPLANTABLE PROGRAMMABLE
REFERRED TO AS 55440-9087 INFUSION PUMP, MODELS 8616-10
MODELS 8631 AND AND 8617-10 THE FOLLOWING
8635) SYNCHROMED INDICATIONS: 1)THE CHRONIC
IMPLANTABLE, INTRASPINAL (EPIDURAL/INTRATHECAL)
PROGRAMMABLE INFUSION OF PRESERVATIVE-FREE
INFUSION PUMP MORPHINE SULFATE STERILE
(10 CC) SOLUTION IN THE TREATMENT OF CHRONIC
INTRACTABLE PAIN, 2)THE CHRONIC
INTRAVASCULAR INFUSION OF
FLOXURIDINE, DOXORUBICIN, CISPLATIN,
OR METHOTREXATE FOR THE TREATMENT
OF PRIMARY OR METASTATIC CANCER AND
3)THE INTRAVENOUS INFUSION OF
CLINDAMYCIN FOR THE TREATMENT OF
OSTEOMYELITIS
P860019/S115 SCIMED RANGER SCIMED LIFE SYSTEMS, INDICATED FOR THE BALLOON DILATATION
09/30/96 WITH XTRA INC. OF THE STENOTIC PORTION OF A
SILICONE COATING MAPLE GROVE, MN CORONARY ARTERY OR BYPASS GRAFT
AND QUANTUM 55311-1566 STENOSIS FOR THE PURPOSE OF
RANGER IMPROVING MYOCARDIAL PERFUSION
PERCUTANEOUS
TRANSLUMINAL
ANGIOPLASTY (PTCA)
CATHETERS
P860023/S010 BAUSCH & LOMB BAUSCH & LOMB, INC. MODIFICATION OF THE CURRENT EYE
09/27/96 RENU MULTI- CARE PRACTITIONER TRIAL LENS
PURPOSE SOLUTION ROCHESTER, NY DISINFECTION AND STORAGE INSTRUCTIONS
14692 TO EXTEND THE MAXIMUM RECOMMENDED
STORAGE TIME FROM THE CURRENTLY
APPROVED 7 DAYS TO 30 DAYS IN
BAUSCH & LOMB RE NU MULTI-PURPOSE
SOLUTION ALL OTHER ASPECTS OF THE
LABELING REMAIN UNCHANGED FROM THOSE
PREVIOUSLY APPROVED
P860059/S076 POLYMETHYLMETHA- ALLERGAN MEDICAL APPROVAL OF MODELS UPB360GN AND
09/17/96 CRYLATE OPTICS UP320F AS TIER A MODIFICATIONS
ULTRAVIOLET- IRVINE, CA OF PREVIOUSLY APPROVED PARENT IOLS
ABSORBING SURFACE 92713-9534 MODEL UPB360GN WILL BE MARKETED UNDER
MODIFIED POSTERIOR THE TRADE NAME TOP NOTCH THE
CHAMBER INTRAOCULAR DEVICES ARE INDICATED FOR PRIMARY
LENSES (IOLS), IMPLANTATION IN THE CILIARY SULCUS
MODELS UPB360GN OR THE CAPSULAR BAG FOR THE VISUAL
AND UP32OF CORRECTION OF APHAKIA IN PERSONS
60 YEARS OF AGE OR OLDER IN WHOM
A CATARACTOUS LENS HAS BEEN REMOVED
BY EXTRACAPSULAR CATARACT EXTRACTION
P870036/S038 MEDTRONIC MEDTRONICS INTRODUCTION OF A NEW PRODUCT LINE
09/25/96 MILLENIA INTERVENTIONAL THE DEVICE IS INDICATED FOR BALLOON
CORONARY BALLOON SAN DIEGO, CA DILATATION OF THE STENOTIC PORTION OF
DILATATION 92121-2256 THE STENOTIC PORTION OF A CORONARY
CATHETER ARTERY OR BYPASS GRAFT STENOSIS FOR
THE PURPOSE OF IMPROVING MYOCARDIAL
PERFUSION
P880027/S040 CHUBBY SLIDING SCHNEIDER (USA), THE DEVICE IS INDICATED FOR BALLOON
09/04/96 RAIL PERCUTANEOUS INC. DILATATION OF THE STENOTIC PORTION
TRANSLUMINAL MINNEAPOLIS, MN OF A CORONARY ARTERY OR BYPASS
CORONARY 55442 GRAFT STENOSIS FOR THE PURPOSE OF
ANGIOPLASTY (PTCA) IMPROVING MYOCARDIAL PERFUSION
CATHETERS
P880028/S007 DEXTRAN HM 32% ABBOTT LABORATORIES APPROVAL TO ALLOW FOR THE ROUTINE
09/05/96 HYSTEROSCOPIC PARAMETRIC RELEASE OF TERMINALLY
DISTENTION MEDIUM ABBOTT PARK, IL MOIST-HEAT STERILIZED SOLUTIONS BY
60064-3537 THE CONTROL OF PROCESS PARAMETERS
FOR DEXTROSE HM 32%
P880038/S033 META III PULSE TELECTRONICS MODIFICATION TO THE LABELING
09/30/96 GENERATOR MODELS PACING SYSTEM, INC. REGARDING THE PROPER INSERTION
1206, 1206E, AND ENGLEWOOD, CO OF A LEAD INTO THE CONNECTOR PORT
1206M 80112
P880086/S036 TRILOGY DR+ PACESETTER, INC. APPROVAL FOR THE TRILOGY DR+
09/30/96 IMPLANTABLE PACING PACING SYSTEM INCLUDING MODELS
SYSTEM SYLMAR, CA 2360L AND 2364L, AND THE MODEL 3203A
91392-9221 FUNCTION PACK
P890001/S016 LEOCOR 30 MM PICO LEOCOR, INC. APPROVAL FOR THE LEOCOR 30 MM
09/17/96 RUNNER PICO RUNNER PERCUTANEOUS
PERCUTANEOUS HOUSTON, TX TRANSLUMINAL CORONARY ANGIOPLASTY
TRANSLUMINAL 77058 (PTCA CATHETER THE DEVICE IS
CORONARY INDICATED FOR BALLOON DILATATION OF
ANGIOPLASTY (PTCA) THE STENOTIC PORTION OF A CORONARY
CATHETER ARTERY OR BYPASS GRAFT STENOSIS FOR
THE PURPOSE OF IMPROVING MYOCARDIAL
PERFUSION
P890003/S044 MEDTRONIC 9891 MEDTRONIC, INC. APPROVAL FOR THE MODELS 9891 AND
09/18/96 AND 9891A 9891A PROGRAMMER SOFTWARE
PROGRAMMER MINNEAPOLIS, MN (BASELINE 7) FOR USE WITH THE MODEL
SOFTWARE FOR USE 55432-3576 9790 AND 9790C PROGRAMMERS
WITH MODEL 9790
9790C PROGRAMMERS
P890027/S034 NUCLEUS 22- COCHLEAR CORP APPROVAL FOR IMPLEMENTING A TEST
09/09/96 CHANNEL COCHLEAR SYSTEM TO CONFIRM OR RULE OUT
IMPLANT SYSTEM ENGLEWOOD, CO POTENTIAL IMPLANT MALFUNCTION AND FOR
80112 MARKETING OF ONE OF THE COMPONENTS
OF THIS TEST SYSTEM AS A SEPARATE
DEVICE
P890027/S036 NUCLEUS 22 COCHLEAR CORP APPROVAL TO CHANGE MATERIAL FOR
09/10/96 CHANNEL COCHLEAR THE CERAMIC LID
IMPLANT ENGLEWOOD, CO
80112
PMA NUMBER/ DEVICE NAME COMPANY NAME/ APPROVAL STATEMENT/INDICATIONS
APPR DATE ADDRESS
P900033/S001 INTEGRA INTEGRA LIFESCIENCES APPROVAL FOR SIZES
09/23/96 ARTIFICIAL SKIN CORP. 8"X10" AND 4"X5"
PLAINSBORO, NJ
08536
P900056/S016 ROTABLATOR BOSTON SCIENTIFIC EXTENSION OF SHELF LIFE OF THE A-19
09/13/96 ROTATIONAL CORP., NORTHWEST ROTABLATOR ADVANCER/CATHETER FROM
ANGIOPLASTY TECHNOLOGY CTR., INC. 2 YEARS TO 4 YEARS
SYSTEM REDMOND, WA
98052-3376
P900056/S017 ROTABLATOR BOSTON SCIENTIFIC REVISED PRODUCT LABELING
09/27/96 ROTATIONAL CORP. NORTHWEST
ANGIOPLASTY TECHNOLOGY CTR., INC.
SYSTEM REDMOND, WA
98052-3376
P900056/S019 ROTABLATOR BOSTON SCIENTIFIC APPROVAL TO MARKET THE RAIL ROTAWIRE
09/04/96 ROTATIONAL CORP. UNDER THE NAME EXTRASUPPORT ROTAWIRE
ANGIOPLASTY REDMOND, WA
SYSTEM WITH THE 98052-6160
ROTAWIRE GUIDE
WIRE LINE
P900061/S023 MODEL 9895E MEDTRONIC, INC. APPROVAL FOR MODEL 9895E APPLICATION
09/25/96 APPLICATION SOFTWARE, VERSION T6E6V3, FOR MODEL
SOFTWARE VERSION MINNEAPOLIS, MN 9790 AND 9790C PROGRAMMERS WHICH
T6E6V3 55432-3576 PROGRAM THE MODELS 7216/7217, 7201
7219/02, AND 7220 IMPLANTABLE
ARRHYTHMIA MANAGEMENT DEVICES
P900066/S002 ISPAN SCOTT MEDICAL PRODUCTS APPROVAL TO ADD A 20 GRAM AND 125
09/24/96 PERFLUOROPROPANE GRAM ALUMINUM LECTURE BOTTLE SIZE
(C3F8) GAS PLUMSTEADVILLE, PA THE DEVICES ARE SURGICAL AIDS AND
18949-0310 ARE INDICATED FOR USE IN THE
TREATMENT OF UNCOMPLICATED RETINAL
DETACHMENTS BY PNEUMATIC RETINOPEXY
P900067/S002 ISPAN SULFUR SCOTT MEDICAL PRODUCTS APPROVAL TO ADD A 20 GRAM AND 125
09/24/96 HEXAFLUORIDE GRAM ALUMINUM LECTURE BOTTLE SIZE
(SF6) GAS PLUMSTEADVILLE, PA THE DEVICES ARE SURGICAL AIDS AND
18949-0310 ARE INDICATED FOR USE IN THE TREATMENT OF UNCOMPLICATED RETINAL
DETACHMENTS BY PNEUMATIC RETINOPEXY
P910019/S002 TEC CORONARY INTERVENTIONAL APPROVAL FOR MODIFICATIONS TO THE
09/17/96 ATHERECTOMY TECHNOLOGIES, INC. REAR SEAL ASSEMBLY OF THE TEC DRIVE
SYSTEM SAN DIEGO, CA COMPONENT OF THE TEC CORONARY
92123 ATHERECTOMY SYSTEM
P910023/S017 PROGRAMMER MODEL VENTRITEX, INC. APPROVAL FOR THE APPLICATION SOFTWARE
09/25/96 PR-1500 SOFTWARE VERSION 4.1G OF THE PROGRAMMER MODEL
VERSION 4.1G SUNNYVALE, CA PR-1500
94086
P910023/S020 VENTRITEX VENTRITEX, INC. APPROVAL FOR THE VENTRITEX CONTOUR
09/09/96 CONTOUR CARDIOVERTER DEFIBRILLATOR SYSTEM
CARDIOVERTER SUNNYVALE, CA (MODELS V-145D AND LT MODEL V-135D,
DEFIBRILLATOR 94086-6527 PROGRAMMER SOFTWARE VERSION 4.1.5.
SYSTEM (MODELS AND ACCESSORIES)
V-145D AND LT
MODEL V-135D,
PROGRAMMER
SOFTWARE VERSION
4.1.5. AND
ACCESSORIES)
P910031/S008 ENDOSONICS ORACLE ENDOSONICS CORP. APPROVAL FOR THE ENDOSONICS ORACLE
09/17/96 MEGASONICS PTCA MEGASONICS PTCA CATHETER
CATHETER RANCHO CORDOVA, CA
95670
P910075/S007 COMPLETE BRAND ALLERGAN OPTICAL APPROVAL FOR A FORMULA MODIFICATION
09/13/96 MULTI-PURPOSE THAT INCLUDES THE ADDITION OF
SOLUTION AND IRVINE, CA HYDROXYPROPYL METHYLCELLULOSE TO
COMPLETE BRAND 92713-9534 THE FORMULATION
LUBRICATING AND
REWETTING DROPS
P910075/S008 COMPLETE BRAND ALLERGAN OPTICAL CHANGE IN THE STERILIZING FILTER
09/05/96 MULTI-PURPOSE (0.22 MICRON)
SOLUTION IRVINE, CA
92713-9534
P910075/S009 COMPLETE BRAND ALLERGAN OPTICAL APPROVAL FOR USE OF A NEW METHOD
09/24/96 MULTI-PURPOSE TO ASSAY THE ACTIVE INGREDIENT,
SOLUTION AND IRVINE, CA POLYHEXAMETHYLENE BIGUANIDE (PHMB)
COMPLETE BRAND 92623-9534
LUBRICATING AND
REWETTING DROPS
P920023/S002 UROLUME AMERICAN MEDICAL APPROVAL TO INCREASE THE NUMBER OF
09/27/96 ENDOPROSTHESIS SYSTEMS, INC. INVESTIGATIONAL SITES FROM 7 TO 8
MINNETONKA, MN FOR THE "POST APPROVAL STUDY FOR
55343 THE UROLUME ENDOPROSTHESIS FOR
TREATING RECURRENT BULBAR URETHRAL
STRICTURE DISEASE."
P930029/S004 ATAKR RFCA MEDTRONIC CARDIORHYTHM APPROVAL FOR 1)ADDITION OF A GRAPH
09/30/96 SYSTEM SHOWING THE RELATIONSHIP OF INITIAL
SUNNYVALE, CA ATAKR POWER OUTPUT TO TEMPERATURE
94089-1113 SET POINT DURING THE RAMP UP PERIOD
IN TEMPERATURE CONTROL MODE; AND 2)
THE ADDITION OF A WARNING STATEMENT
REGARDING PROPER CONNECTION
TECHNIQUES WHEN UTILIZING THE ATAKR
SYSTEM WITH OTHER CATHETER LABORATORY
EQUIPMENT
P930029/S007 ATAKR MEDTRONIC APPROVAL FOR A MANUFACTURING SITE
09/06/96 RADIOFREQUENCY CARDIORHYTHM LOCATED AT MEDTRONIC CARDIORHYTHM,
CATHETER ABLATION SAN JOSE, CA SUNNYVALE, CALIFORNIA
SYSTEM 95134-1806
PMA NUMBER/ DEVICE NAME COMPANY NAME/ APPROVAL STATEMENT/INDICATIONS
APPR DATE ADDRESS
P940029/S002 PAPNET NEUROMEDICAL SYSTEMS, APPROVAL FOR MODIFICATIONS TO THE
09/30/96 TESTING SYSTEM INC. MAPPING UNIT USED IN THE PAPNET
SUFFERN, NY TESTING SYSTEM THE DEVICE, AS
10901-4164 MODIFIED, WILL BE MARKETED UNDER
THE TRADE NAME INDEPENDENT MAPPING
UNIT (IMU) AND IS AN AUTOMATED
SYSTEM FOR DELINEATING SLIDE EDGE
BOUNDARIES
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